Trial Review

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Measuring the human urethral pressure with the standard Microtip catheter and the new 7-channel catheter and assessment of agreement of the two catheters in a prospective comparative study

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Secondary ID [1]2528850

nil

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Universal Trial Number (UTN)

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Trial acronym

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Linked study record

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Health condition

Health condition(s) or problem(s) studied:

Physiological urethral pressure in healthy human volunteers2584170

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Condition category

Condition code

Renal and Urogenital25858425858400

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Normal development and function of male and female renal and urogenital system

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Intervention/exposure

Study type

Interventional

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Description of intervention(s) / exposure

The urethral pressure is measured with the standard urethral pressure catheter Microtip. After this measurement the urethral pressure is measured again with the new 7-channel catheter. The intervention is a part of a urodynamic evaluation for which the women are scheduled. Each measurement is taken once in each patient.

The microtip catheter is has 2 sensors (one in the bladder, one in the urethra) and is withdrawn through the urethra using a mechanical puller at a constant speed. Measurement take about 1 minute.

The 7-channel catheter has 7 individual sensors at 5 mm distance between each of them, size 8 French, flexible. It is not withdrawn. Measurement take about 1 minute.

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Intervention code [1]2574130

Diagnosis / Prognosis

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Comparator / control treatment

The control of the new 7-channel catheter is the standard Microtip catheter.

- pains: assessment before, during and immediately after the procedure.

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Eligibility

Key inclusion criteria

A continuous series of women scheduled for a urodynamic evaluation.

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Minimum age

18Years

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Maximum age

No limit

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Gender

Females

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Can healthy volunteers participate?

Yes

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Key exclusion criteria

Urinary tract infection.

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Study design

Purpose of the study

Diagnosis

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Allocation to intervention

Non-randomised trial

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Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures)

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Methods used to generate the sequence in which subjects will be randomised (sequence
generation)

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Masking / blinding

Open (masking not used)

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Who is / are masked / blinded?

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Intervention assignment

Single group

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Other design features

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Phase

Not Applicable

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Type of endpoint(s)

Safety/efficacy

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Statistical methods / analysis

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Recruitment

Recruitment status

Completed

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Date of first participant enrolment

Anticipated

1/01/2003

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Actual

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Date of last participant enrolment

Anticipated

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Actual

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Date of last data collection

Anticipated

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Actual

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Sample size

Target

21

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Accrual to date

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Final

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Recruitment outside Australia

Country [1]29760

Switzerland

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State/province [1]29760

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Funding & Sponsors

Funding source category [1]2578550

Hospital

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Name [1]2578550

Department of Urology, University of Bern

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Address [1]2578550

InselspitalAnna Seiler-HausCH-3010 Bern

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Country [1]2578550

Switzerland

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Primary sponsor type

Hospital

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Name

Department of Urology, University of Bern

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Address

InselspitalAnna Seiler-HausCH-3010 Bern

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Country

Switzerland

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Secondary sponsor category [1]2570820

None

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Name [1]2570820

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Address [1]2570820

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Country [1]2570820

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Ethics approval

Ethics application status

Not yet submitted

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Summary

Brief summary

This study has not been judged by an official ethics committee, which has a HREC Number. At this time around 2002, this kind of small studies was discussed and ethically judged and eventually approved by the staff of the Department of Urology, University of Bern.

The purpose of this study was to compare the standard microtip catheter with the new 7-channel catheter in terms of accuracy and safety measuring the urethral pressure. Both measurements are very similar, easy to do and non-invasive. The catheter in placed into the urethra, like a foley catheter. The hypothesis was, that the measurement with the 7-channel catheter was even accurate and less uncomfortable for patients, because it was not withdrawn. With about 1 minute both measurements were short. Based on the experience with the microtip catheter, no side effects, like pain, were expected